RecruitingNCT06210776

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Sponsor

Daiichi Sankyo

Enrollment

800 participants

Start Date

Jan 15, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer HER2-low Breast Cancer HER2-positive Breast Cancer Advanced Cancer

Summary

This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how effective the drug trastuzumab deruxtecan (T-DXd) is for Chinese patients with breast cancer that has spread (metastatic). It includes two groups: those with HER2-positive tumors and those with a lower level of HER2 called HER2-low. This helps understand how the drug performs across different HER2 levels. **You may be eligible if...** - You are 18 or older with unresectable or metastatic breast cancer - Your tumor is HER2-positive (confirmed by standard testing) and you have received 1–2 prior anti-HER2 treatments, OR - Your tumor is HER2-low and you have received prior chemotherapy for metastatic disease - You are in adequate health and have measurable tumors **You may NOT be eligible if...** - You have not received the required prior treatments - You have active brain metastases that are uncontrolled - You have serious lung disease or other conditions that make the drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab deruxtecan

Intravenous infusion

Locations(54)

China-Japan Friendship Hospital

Beijing, China

Peking University First Hospital

Beijing, China

The Fifth Medical Center of the Chinese PLA General Hospital

Beijing, China

Peking University Shougang Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing GoBroad Hospital

Beijing, China

Sichuan Cancer Hospital

Chengdu, China

Sichuan Provincial People's Hospital

Chengdu, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, China

The First People's Hospital of Foshan

Foshan, China

Fujian Cancer Hospital

Fuzhou, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Hainan Cancer Hospital

Haikou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Anhui Provincial Cancer Hospital

Hefei, China

Jiamusi Cancer Hospital

Jiamusi, China

Yunnan Cancer Hospital

Kunming, China

The First People's Hospital of Lianyungang

Lianyungang, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

Jiangxi Cancer Hospital

Nanchang, China

Nanchang Third Hospital

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Jiangsu Province Hospital

Nanjing, China

The Peoples of Guangxi Zhuang Autonomous Region

Nanning, China

Affiliated Hospital Of Nantong University

Nantong, China

Ningbo No.2 Hospital

Ningbo, China

Qingdao Central Hospital

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Changhai Hospital

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Liaoning Cancer Hospital & Institute

Shenyang, China

The University of Hong Kong- Shenzhen Hospital

Shenzhen, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

Tangshan People's Hospital

Tangshan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

Weifang People's Hospital

Weifang, China

Wenzhou Central Hospital

Wenzhou, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Xi'an International Medical Center Hospital

Xi'an, China

The First Affilital of Xiamen University

Xiamen, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

General Hospital of Ningxia Medical University

Yinchuan, China

Henan Cancer Hospital

Zengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Henan Provincial People's Hospital

Zhengzhou, China

Zhongshan City People's Hospital

Zhongshan, China

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, China

View Full Details on ClinicalTrials.gov

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NCT06210776

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